Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don't settle for the mediocre. Each of us is driven to help improve patients lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Job Responsibilities

Act as PDO Support within its product family and technical expert for projects in development and lifecycle management activities within R&D Kidney Care Solutions Development
Organize, plan and execute sustaining activities in compliance with current QA/ environmental/ regulations and standards
Review and approve Design Control documentation for projects in development and sustaining activities.
Responsible and accountable for the design history files of a given product family
Establish, maintain and update technical specifications describing product appearance, characteristics and functions, and associated verification and validation documents
Organize, plan and follow the execution of product changes, supplier changes and labelling tasks related to life cycle management projects
Support worldwide product registration and launch following, international/regional/national regulations; provide technical support to authorities questions
Provide technical leadership for products/process/cost improvements related to life cycle management projects
Provide resource estimation and forecast
Ensure good internal and cross-functional communication at a global front and regular status update of projects

Qualifications

Master's in chemistry or M. Pharm. with at least 7 years of relevant experience or Ph.D. in relevant sciences discipline with at least 3 years of relevant experience.
Excellent English verbal and written communication skills
Exposure to medical devices and drug products
Good knowledge of product development stages and life cycle management: development, stability, clinical, registration, process transfer, production, suppliers, customer service
Demonstrated project/program leadership in drug/pharmaceutical products
Exposure to Product Risk Management for medical devices and drug products
Working knowledge of international/regional/national regulations and standards
Experience in project management and stakeholder management at a global front
Ability to work independently.

Skills

Excellent English verbal and written communication skills.
Self-directed, resourceful, and able to work on multiple projects and priorities.
Strong organization, attention to detail, and documentation skills.
Very adept at grasping and solving complex problems using root-cause analysis techniques.
Ability to objectively identify technical solutions and make sound decisions.

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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Research Associate II